Feyissa GD. Sex-related differences in treatment outcomes of chronic hepatitis C with direct-acting antivirals. World J Hepatol 2025; 17(10): 110430 [PMID: 41179721 DOI: 10.4254/wjh.v17.i10.110430]
Corresponding Author of This Article
Gemechu Dereje Feyissa, Assistant Professor, Department of Public Health, Faculty of Health Sciences, Rift Valley University, Hangatu District, Dabe Sub-city, Adama 1715, Oromīa, Ethiopia. gemechudereje80@gmail.com
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Gastroenterology & Hepatology
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Editorial
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Oct 27, 2025 (publication date) through Nov 17, 2025
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World Journal of Hepatology
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Feyissa GD. Sex-related differences in treatment outcomes of chronic hepatitis C with direct-acting antivirals. World J Hepatol 2025; 17(10): 110430 [PMID: 41179721 DOI: 10.4254/wjh.v17.i10.110430]
Author contributions: Feyissa GD has played important and indispensable roles in the manuscript preparation, read and approved the final version of the manuscript to be published.
Conflict-of-interest statement: There are no conflicts of interest.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Gemechu Dereje Feyissa, Assistant Professor, Department of Public Health, Faculty of Health Sciences, Rift Valley University, Hangatu District, Dabe Sub-city, Adama 1715, Oromīa, Ethiopia. gemechudereje80@gmail.com
Received: June 7, 2025 Revised: June 19, 2025 Accepted: August 22, 2025 Published online: October 27, 2025 Processing time: 143 Days and 18.1 Hours
Abstract
This editorial provides commentary on the study by Dobrowolska et al, highlighting the influence of biological sex on hepatitis C virus (HCV) infection risk and disease progression. HCV infection is more common in men; however, women, regardless of age, show a lower prevalence of genotype 3 infection, diabetes mellitus, and coinfections with hepatitis B virus and human immunodeficiency virus. Women also experience slower liver fibrosis progression. Despite this, mild adverse events, autoimmune diseases, and depression occur more frequently in women. Sustained virologic response at 12 weeks post-treatment was significantly higher in women (98.4%) than in men (96.6%). In women, postmenopausal status, genotype 3 infection, and cirrhosis were independently associated with treatment failure. Early diagnosis and timely antiviral therapy in women are critical to preventing vertical transmission and mitigating disease advancement.
Core Tip: Sex influences the epidemiology, progression, and treatment outcomes of chronic hepatitis C. Women exhibit lower body mass index, less genotype 3 infection, and fewer hepatitis B virus/human immunodeficiency virus coinfections compared to men. They have slower liver fibrosis progression and achieve higher sustained virologic response rates with direct-acting antivirals. However, postmenopausal women report more treatment-related adverse events. Recognizing these sex- and reproductive status-related differences is crucial to optimize personalized management and improve therapeutic outcomes in chronic hepatitis C patients.
Citation: Feyissa GD. Sex-related differences in treatment outcomes of chronic hepatitis C with direct-acting antivirals. World J Hepatol 2025; 17(10): 110430
The biological sex, encompassing hormones, chromosomes, and reproductive anatomy, is an independent and significant factor influencing both the susceptibility to hepatitis C virus (HCV) infection and the disease course[1]. Men have a higher likelihood of contracting HCV. For instance, data from 2020 show that men accounted for approximately two-thirds of all reported HCV cases in Europe, with this male predominance consistent across all age groups[2]. One underlying mechanism contributing to this disparity is the higher rate of spontaneous viral clearance observed in women.
A key factor is the female sex hormone 17β-estradiol, which promotes an antiviral environment in liver cells by activating type I interferon (IFN). This activation impedes HCV entry into hepatocytes, as well as subsequent viral protein folding and release, thereby increasing the likelihood of viral clearance. Additionally, women typically have higher counts of CD4+ T cells compared to men, which plays a crucial role in the acute phase of HCV infection by supporting a vigorous antiviral immune response to eliminate the virus[3,4]. These sex-related immunological and hormonal differences underpin the observed variations in infection risk and natural history of HCV between males and females.
Behaviors that facilitate the transmission of HCV are closely linked to its incidence. Accordingly, the epidemiology of HCV infection with respect to sex has recently evolved[5]. These changes are particularly notable among women of reproductive age due to the risk of vertical transmission, which is a significant public health concern[6]. The opioid epidemic has contributed to increased drug use among women, further influencing this trend[7]. Therefore, early prevention, screening, and treatment of HCV in young women-ideally before pregnancy-are critical to reduce vertical transmission and adverse perinatal outcomes associated with HCV infection[8]. Successful management of hepatocellular carcinoma (HCC) and HCV infection contributes to decreasing liver-related and all-cause mortality[9].
Rates of liver fibrosis (LF) and progression to cirrhosis are observed to be slower in younger women compared to men of the same age, which highlights the importance of early detection and initiation of antiviral therapy in this population. However, this sex-based difference in fibrosis progression diminishes in older women, likely due to hormonal changes associated with menopause, such as the decline in estrogen levels[10,11]. The introduction of direct-acting antivirals (DAAs) has markedly transformed the treatment landscape for patients with chronic HCV infection, achieving high sustained virologic response rates at 12 weeks post-treatment (SVR12)[12]. This editorial focuses on examining how biological sex influences the clinical outcomes of patients receiving DAAs for chronic HCV infection.
SEX-SPECIFIC SUSTAINED VIROLOGIC RESPONSE OUTCOMES WITH DAA
Patient characteristics by sex and age group
The study by Dobrowolska et al[13], published in the World Journal of Hepatology, included 18986 patients receiving DAA treatment for chronic HCV infection. To facilitate comparisons with age-matched men, the authors stratified women into three groups based on reproductive status: Pre-menopausal, menopausal, and post-menopausal, as detailed in Table 1.
Table 1 Summary of baseline characteristics by sex and age group, n (%).
Women consistently presented with lower median body mass index (BMI) across all age groups compared to men. Genotype 1B predominated both sexes, but women showed a notably lower prevalence of genotype 3 infection, particularly in older age groups. Pangenotypic DAA use was slightly more frequent in men, despite similar genotype distribution, suggesting possible differences in prescription patterns or access (Table 1).
Notably, although there was no significant difference in the seroprevalence of HCV antibodies between men and women, a meta-analysis focusing on Egyptian residents revealed that men were more frequently found to be positive for HCV RNA than women[14]. Conversely, a study conducted within the Dallas County Jail identified a significant correlation between HCV antibody positivity and female sex[15]. As illustrated in Table 1, men exhibited a higher BMI across all age groups compared to women. This finding aligns with other research indicating that men have a greater propensity to be overweight[16].
Sex-based comorbidity differences across age groups
As shown in Table 2, men exhibited higher rates of comorbid conditions such as diabetes mellitus, hypertension, renal disease, and human immunodeficiency virus (HIV) co-infection across all age strata. Conversely, women had higher prevalence of autoimmune diseases and depression[17,18]. The burden of comorbidities increased with age in both sexes, with over 80% of patients older than 55 years having at least one comorbid condition.
Table 2 Sex-based comorbidity differences across age groups, n (%).
Regarding viral coinfections, men were more likely to be coinfected with both HIV and hepatitis B virus (HBV) compared to women, although the difference in HBV coinfection was not deemed clinically significant. Notably, HIV coinfection was less common in women across all age groups relative to HBV coinfection. Overall, men had a significantly higher likelihood of coinfection with both HIV and HBV throughout all age categories[19]. These sex-based differences in comorbidity profiles underscore the importance of evaluating how such factors influence treatment efficacy and safety outcomes in chronic HCV patients.
Treatment outcomes
Understanding sustained virologic response (SVR) rates by sex provides critical insight into the effectiveness of DAAs across different patient subgroups. The study by Dobrowolska et al[13], published in the World Journal of Hepatology, was the first to evaluate sex-related differences in patients with chronic HCV infection treated with DAAs. The effectiveness of antiviral treatment was assessed by measuring HCV RNA SVR12. As shown in Table 3, SVR12 rates were high in both sexes and all age groups, with women achieving slightly higher intent-to-treat (ITT) and per-protocol (PP) SVR12 than men. Postmenopausal women had lower SVR12 rates than younger women, emphasizing the influence of hormonal and age-related factors on treatment outcomes. Figure 1 displays the ITT SVR12 rates in chronic HCV patients treated with DAAs, separated by age group (15-44, 45-55, > 55 years) and sex.
Figure 1 Sustained virologic response at 12 weeks post-treatment by age group and sex.
Color gradients indicate the magnitude of response success, and each cell shows the precise sustained virologic response at 12 weeks post-treatment percentage for clarity. SVR12: Sustained virologic response at 12 weeks post-treatment.
Table 3 Summary of sustained virologic response and adverse events stratified by age and sex, n (%).
The prevalence and distribution of HCV genotypes are significantly influenced by geographic and behavioral factors, including sex-related differences. Treatment regimens included both GT-specific and pan-genotypic DAAs, as shown in Table 1. The analysis shows that pangenotypic treatment options are more frequently prescribed to males than females, although genotype distribution is similar between sexes[20]. GT1 was the most prevalent genotype, followed by GT3 and GT4, consistent with findings from southern Iran[21]. Conversely, a retrospective Saudi Arabian study reported GT4 as the most common genotype, followed by GT1[12].
Clinical trial analyses demonstrated that women with HCV GT1 or GT3 infections had a higher likelihood of achieving SVR12 compared to men[22]. Men were more frequently infected with GT3 regardless of age, as reflected in Table 1. Various Western studies have linked intravenous drug use (IDU) to greater GT3 prevalence; however, these studies did not differentiate between intravenous and non-IDU. HCV genotype 3 is more prevalent among IDUs due to shared needle usage, and this pattern can vary by geographic location. Additionally, behavioral factors like sexual practices, particularly among men who have sex with men (MSM), can also affect genotype distribution. Notably, women who inject drugs might be more vulnerable to HCV infection than men[5]. Genotype distribution also varies geographically for instance, GT4 dominates in Africa, while GT2 and GT6 are more common in Asia[23]; in other regions, GT1, GT3, and GT6 predominate[24]. GT4's spread in Europe is largely driven by migration and HCV transmission among HIV co-infected individuals[25]. HCV genotypes and subtypes are not uniformly distributed worldwide. Migration patterns, healthcare infrastructure, and socioeconomic factors contribute to these geographic variations. For example, genotype 1 predominates in Central and Eastern Europe, whereas genotype 3 is more common among IDU in certain regions.
A retrospective analysis of HCV-infected patients treated with DAAs at a Saudi tertiary university hospital reported an SVR12 rate of 98.3%[12], with treatment failure in 4.7% of patients[26]. Similarly, 97.5% of chronic HCV patients in Saudi Arabia achieved SVR12, with no significant differences observed when data were stratified by cirrhosis, age, sex, or HCV genotype[27]. ITT and PP analyses indicated women were slightly more likely than men to achieve SVR12, although these differences lacked clinical significance. These results are consistent with findings from Egypt, showing a marginally higher SVR12 in females compared to males[28]. SVR12 rates did not differ between individuals with HCV genotype 1 mono-infection vs those with HCV genotype 1/HIV-1 co-infection[22]. Regardless of sex, younger women had the most favorable treatment outcomes, while postmenopausal women had the least favorable, though these disparities were not clinically significant (Table 3).
Factors independently associated with treatment failure included alcohol use, male sex, prior therapy history, GT3 infection, and cirrhosis. These findings align with a Brazilian retrospective cohort study identifying male sex as an independent risk factor for virological failure[29]. Conversely, women on DAA regimens generally demonstrated high SVR12 rates[22]. In females, age over 55 years, cirrhosis, and GT3 infection independently predicted a higher likelihood of virological failure, with age above 55 being the sole independent predictor of increased viral loads[30]. Both gender and cirrhosis status independently forecasted poor treatment response[27]. In addition to efficacy, sex differences may also manifest in the frequency and severity of treatment-related adverse events (AE), which can impact overall patient management.
AEs by gender: Frequency and clinical significance
As demonstrated in Table 3, women reported AEs more frequently than men across all age groups, although these differences were not clinically significant. This finding aligns with data from Egypt, where women similarly reported higher rates of AEs during DAA treatment[28]. Commonly reported symptoms among women included headache, exhaustion, and nausea, which may be attributable to a higher susceptibility to adverse drug reactions from DAAs[22,28]. Notably, headache and weakness/fatigue were the most prevalent AEs reported, yet sex-related variations in their frequency lacked clinical significance, consistent with observations from a Saudi tertiary hospital study[12]. AEs were more common in women particularly mild events such as weakness, fatigue, and headache but severe AE rates and mortality were comparable (Table 3).
Beyond geographic contexts, women in various populations have been shown to report AEs more frequently, may be more responsive to health advice from social networks, and are generally more proactive in seeking health information[31]. In a Chinese cohort, older patients (≥ 60 years) treated with DAAs also exhibited increased AE rates compared to younger counterparts[32]. Conversely, a retrospective multicenter observational study reported no treatment-related AEs in any cases[33].
Men reported serious AEs and deaths at a higher frequency than women. Two men who experienced severe AEs had undergone liver transplants due to prior HCC before initiating DAA therapy. A systematic review and meta-analysis revealed a substantially reduced risk of HCC occurrence in chronic HCV patients who achieved SVR12 compared to non-responders[34]. However, DAA use has also been linked to increased hepatic steatosis in some studies[35]. A prospective trial confirmed that generic DAA-induced SVR12 remains effective in patients with advanced cirrhosis, yielding favorable clinical outcomes despite a persistent risk of hepatocarcinogenesis[33]. The incidence of hepatic encephalopathy and ascites was rare, further validated by a previous trial showing no significant treatment-emergent severe AEs[36]. Mortality was observed more frequently in men, with the majority of death causes (74.34%) unidentified. Exploratory analyses indicated that cardiovascular disease, coinfections, and failure to achieve SVR12 were associated with higher mortality risks in chronic HCV patients[37]. Figure 2 shows rates of mild and severe AEs for women and men across all age groups.
Figure 2 Mild and severe adverse event rates by sex and age group for direct-acting antivirals-treated hepatitis C virus patients.
Mild adverse event (AE) represent any reported event, while severe AEs comprise liver transplant, hepatocellular carcinoma, and decompensated liver cirrhosis. AE: Adverse event.
While DAAs have revolutionized HCV therapy, it is important to acknowledge that various DAA classes such as NS5A inhibitors, NS3/4A protease inhibitors, and NS5B polymerase inhibitors may differ in efficacy and AE profiles between sexes. Some evidence suggests that women might experience higher rates of certain adverse effects or pharmacokinetic variations with specific DAA regimens, potentially influencing tolerability and outcomes[38].
However, most studies, including the ones referenced here, do not stratify treatment outcomes or side effects by DAA class and sex simultaneously, limiting the ability to draw firm conclusions. Future investigations should evaluate whether sex-specific variations in drug metabolism or immune response lead to differential efficacy or toxicity across different DAA therapies, to guide personalized treatment selection[39].
Clinical implications of reproductive and hormonal status
The impact of reproductive status, notably menopause, is evident in treatment outcomes and disease progression. Postmenopausal women exhibit poorer responses compared to younger women, underscoring the role of hormonal factors in HCV pathophysiology and therapy effectiveness. Estrogen’s protective effects on the liver may account for this disparity[40]. These observations emphasize the need for sex- and age-specific approaches in clinical management.
Role of hormonal factors
Sex hormones, particularly estrogen, play a significant role in modulating the natural history and treatment response of chronic hepatitis C infection. Estrogen exerts hepatoprotective effects through multiple mechanisms, including reducing hepatic stellate cell activation and fibrogenesis, which contributes to slower progression of LF in premenopausal women compared to men and postmenopausal women. Furthermore, estrogen influences immune system functioning by modulating both innate and adaptive immune responses, promoting enhanced viral clearance while also predisposing women to autoimmune phenomena[41,42].
Estrogen receptors (ERα and ERβ) are expressed in liver tissue and immune cells, where they impact gene expression involved in inflammation and fibrosis. Clinical studies have shown that lower estrogen levels during menopause correlate with accelerated LF and poorer outcomes in HCV infection, highlighting the clinical relevance of hormonal status in disease progression and treatment efficacy. The precise pathways linking estrogen signaling to HCV pathogenesis remain an active area of research with implications for targeted therapies[43,44].
Further research is necessary to elucidate the precise biological mechanisms through which hormonal changes influence HCV pathogenesis and therapeutic response. This includes investigating the potential impacts of hormone replacement therapy and contraceptive use on disease progression and treatment outcomes.
Fibrosis progression trends across sex and age groups
The study's authors found that, irrespective of age, men were more likely than women to have cirrhosis, which represents advanced LF. This sex difference in fibrosis progression was most pronounced among individuals aged 45 to 55 years, as illustrated in Figure 3. Similar findings have been reported in Egypt, where males exhibited significantly higher LF than females[28]. A systematic review and meta-analysis demonstrated that the risk of HCC after achieving SVR at SVR12 was three times higher for patients with cirrhosis compared to those without[34]. Other studies reported that 43.2%[12] and 6.75%[45] of LF cases progressed to cirrhosis across their study populations, respectively. Importantly, successful HCV eradication with DAAs has been associated with significant improvements in fibrosis[46,47]. The protective effect of sex hormones partly explains the slower progression of LF and lower incidence of cirrhosis in younger women compared to men[48]. The authors noted that the risk of fibrosis progression in women fluctuates over time in close relation to reproductive status. Estrogen and estradiol receptors in the liver protect hepatocytes against oxidative stress, inflammation, and cell death, but during menopause when hormonal influence wanes fibrosis accelerates, equalizing gender differences[49]. Progression from fibrosis to cirrhosis, portal hypertension, liver failure, and ultimately HCC worsens patient outcomes. Biological modifiers such as sex, alongside sociocultural constructs like gender, influence LF development through an interplay of genetic, hormonal, immunological, metabolic, and lifestyle factors including diet, alcohol consumption, physical activity, and hormone therapy. Additionally, the etiology of chronic liver disease, patient age, and reproductive status substantially impact hepatic fibrosis progression[48].
Figure 3 Fibrosis progression trends by sex and age group.
Screening and early diagnosis of HCV
To optimize care for women of reproductive age, it is crucial to implement screening and early diagnosis of HCV infection, alongside counseling for reproductive planning before and during antiviral therapy[50]. Population-wide screening, including birth cohort testing, has been shown to reduce the costs associated with chronic HCV infection and its complications[51]. A significant gap exists in identifying children born to HCV-infected mothers, as pediatric populations are often not screened adequately. This gap adversely affects linkage to care and treatment, a concerning outcome given the availability of highly effective antiviral medications[52-55]. Globally, the combination of DAA therapy, behavioral prevention strategies, and expanded HCV screening continues to reduce HCV-associated comorbidities[56]. Innovative approaches, such as the application of machine learning algorithms to predict mortality risk in chronic HCV patients, offer promising tools for personalized risk stratification and tailored treatment[37]. The advent of DAAs, characterized by excellent cure rates, minimal side effects, and shortened treatment courses, represents a significant breakthrough in HCV management[57].
Literature engagement and global contextualization
The sex-related differences in chronic HCV infection outcomes observed in Polish and Middle Eastern cohorts align with, yet also diverge in nuanced ways from, findings reported in other global regions. For example, in United States populations, several studies have demonstrated slower fibrosis progression and higher SVR rates among women compared to men, particularly in premenopausal women. This has been attributed to both hormonal influences and differential behavioral risk factors. Similarly, Asian cohorts have also reported sex-specific disparities in genotype distribution and fibrosis severity, with women generally exhibiting less aggressive disease[58,59].
In Africa, where genotype diversity is higher and healthcare access variable, sex differences in treatment outcomes appear less marked, though data remain limited. Here, socioeconomic factors and healthcare infrastructure potentially overshadow biological sex effects, underscoring the complex interplay of biology and context in HCV epidemiology[60].
The study by Dobrowolska et al[13], which forms the basis of this editorial, offers important numeric insights: Women achieved an impressive SVR12 of 98.4%, surpassing the 96.6% observed in men, although the difference was not statistically significant. The study also highlights that postmenopausal age, genotype 3 infection, and cirrhosis were associated with treatment failure in women. Such detailed reporting on key demographic and virologic parameters strengthens the understanding of sex-specific factors influencing treatment response.
Together, these findings reinforce that while biological sex is an influential factor in HCV infection and treatment, it must be interpreted within a broader global and demographic context. Regional differences in genotype prevalence, healthcare access, behavioral risk, and co-morbid conditions play pivotal roles in modifying these associations.
Evidence interpretation and limitations
While several studies, including the one analyzed here, observe differences in SVR12 between women and men, it is important to highlight that many of these differences lack statistical significance or clinical relevance. For example, although women in some cohorts demonstrated slightly higher SVR12 rates than men, the magnitude of these differences was modest and did not consistently translate into improved long-term clinical outcomes. Therefore, assertions such as “women respond better to treatment” should be interpreted with caution and framed within the context of these limitations.
It is also essential to recognize that the primary data sources, including the cohort analyzed by Dobrowolska et al[13], predominantly represent a Polish patient population. Extrapolation of these findings to broader, more diverse global populations should be undertaken carefully, considering geographical variations in genotype distribution, healthcare access, and social determinants.
Additional factors not captured in many datasets-such as adherence to treatment regimens, behavioral risk factors, comorbid substance use, and socioeconomic status-may substantially influence treatment outcomes and could confound observed sex differences. Absence of these variables limits the ability to fully elucidate mechanisms underlying sex-based disparities in HCV infection and its treatment.
Future research incorporating more diverse populations and comprehensive data collection is required to clarify the interplay of biological, behavioral, and social factors contributing to observed sex differences in chronic HCV outcomes.
Future research suggestions
To further elucidate the complex interplay of biological, behavioral, and social factors driving sex-based differences in chronic hepatitis C treatment outcomes, there is an urgent need for prospective, multinational cohort studies. These studies should incorporate comprehensive longitudinal data capturing hormonal status, treatment adherence patterns, behavioral risk factors, and detailed clinical outcomes. Inclusion of diverse populations across multiple geographic regions will enhance the generalizability and global applicability of findings.
Moreover, the establishment of pharmacovigilance registries systematically tracking AEs associated with DAAs, stratified by sex, age, and treatment regimen, is essential. Real-world evidence from such registries will provide critical insights into sex-specific safety profiles of different DAA classes, thereby informing personalized therapeutic choices and optimizing patient care.
By pursuing these research priorities, the hepatology field can advance toward a more nuanced understanding and tailored management of chronic hepatitis C infection that fully integrates sex and reproductive status. Such efforts will ultimately improve treatment outcomes and contribute to reducing disparities in care worldwide.
CONCLUSION
This editorial underscores the significant influence of biological sex and reproductive status on the natural history, treatment response, and AE profiles in chronic hepatitis C infection treated with DAAs. While SVR12 rates are consistently achieved across both sexes, postmenopausal women exhibit relatively lower SVR12 rates and a heightened frequency of AEs, particularly autoimmune and psychiatric conditions.
These observations emphasize the necessity for vigilant clinical monitoring and individualized management strategies tailored to this vulnerable subgroup. Clinicians are encouraged to incorporate sex and menopausal status into their treatment planning and follow-up protocols, ensuring timely identification and management of AEs and close monitoring of fibrosis progression. Furthermore, patient education and support should be customized to address the distinct challenges encountered by women at various reproductive stages, thereby fostering improved adherence and therapeutic outcomes.
Importantly, future hepatitis C management guidelines should explicitly integrate sex and reproductive status stratification. The inclusion of sex-specific recommendations will facilitate optimized risk assessment, therapeutic decision-making, and monitoring strategies, ultimately enhancing personalized care and improving clinical outcomes for all patients affected by chronic hepatitis C.
Footnotes
Provenance and peer review: Invited article; Externally peer reviewed.
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